Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-01 @ 7:11 AM
Study NCT ID:
NCT02532868
Status:
TERMINATED
Last Update Posted:
2015-08-26
First Post:
2014-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C484810', 'term': 'tozasertib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2014-07-18', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 21 days'}], 'secondaryOutcomes': [{'measure': 'Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans', 'timeFrame': 'Predose, and at end of Cycles 2 and 6 (up to approximately 4 months)'}, {'measure': 'Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'Pre-dose through post-study visit (up to 3 years)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '20386909', 'type': 'DERIVED', 'citation': "Traynor AM, Hewitt M, Liu G, Flaherty KT, Clark J, Freedman SJ, Scott BB, Leighton AM, Watson PA, Zhao B, O'Dwyer PJ, Wilding G. Phase I dose escalation study of MK-0457, a novel Aurora kinase inhibitor, in adult patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Feb;67(2):305-14. doi: 10.1007/s00280-010-1318-9. Epub 2010 Apr 13."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.\n\nExclusion Criteria:\n\n* Patients who have had treatment with any investigational therapy within the past 30 days.\n* Patients who have certain types of blood cancers such as leukemia or lymphoma.\n* Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation.\n* Patient is pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT02532868', 'briefTitle': 'A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)', 'nctIdAliases': ['NCT00104351'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase I Dose Escalation Study of MK0457 Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a 24-Hour Continuous Infusion Given Every 21 Days in Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': '0457-002'}, 'secondaryIdInfos': [{'id': '2005_005'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-0457', 'description': 'Participants received MK-0457 at assigned dose as a continuous intravenous infusion (CIV) over 24 hours; one group of participants also received MK-0457 100 mg capsules, orally, prior to the CIV.', 'interventionNames': ['Drug: MK-0457']}], 'interventions': [{'name': 'MK-0457', 'type': 'DRUG', 'otherNames': ['VX-680 (an Aurora Kinase Inhibitor)'], 'armGroupLabels': ['MK-0457']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}